commercially available lansoprazole for Asthma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Nemours Children's Specialty Care, Jacksonville, FL
Asthma+1 More
commercially available lansoprazole - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a specific genetic test may help determine the best dose of a medication for children with gastroesophageal reflux disease (GERD) and asthma.

See full description

Eligible Conditions

  • Asthma
  • Gastroesophageal Reflux

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether commercially available lansoprazole will improve 1 primary outcome and 6 secondary outcomes in patients with Asthma. Measurement will happen over the course of Week 0 (baseline) through Week 26.

Week 26
Change in Lung Function Testing from Screening through Week 26
Measured at weeks -2 (screening), 0 (baseline), 4, 8, 12,16, 20, 26
Change in GERD Symptom Assessment Questionnaire Score (GSAS) from Screening through Week 26
Measured at weeks -2 (screening), 0 (baseline), 8, 16, 26
Change in Asthma Control Questionnaire (ACQ) from Screening through Week 26
Change in Asthma Symptom Utility Index (ASUI) from Screening through Week 26
Week 26
Annualized rate of Episodes of Poor Asthma Control (EPAC)
Annualized rate of asthma exacerbations
Annualized rate of respiratory tract infection (RTI)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Genotype-guided Lansoprazole
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 110 total participants across 2 different treatment groups

This trial involves 2 different treatments. Commercially Available Lansoprazole is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Genotype-guided Lansoprazole
Drug
participants will receive oral blinded commercially available lansoprazole once daily with a dose appropriate for the participant's metabolizer phenotype
Placebo
Drug
participants will receive oral blinded matched placebo once daily

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured at weeks -2 (screening), 0 (baseline), 4, 8, 12,16, 20, 26
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly measured at weeks -2 (screening), 0 (baseline), 4, 8, 12,16, 20, 26 for reporting.

Closest Location

Nemours Children's Specialty Care - Jacksonville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age: 6-17 year olds with documented clinician-diagnosed asthma
Evidence of recent uncontrolled asthma (must meet at least one of the following). This convention for defining poorly-controlled asthma has been successfully used in a large pediatric trial.
ACQ > 1.2
Use of short-acting beta-agonist for asthma symptoms twice/week or more on average over the past month
Nocturnal awakenings with asthma symptoms more than once per week on average over the last month
Two or more emergency department visits, unscheduled provider visits, prednisone courses or hospitalizations for asthma in the past 12 months
Currently on stable dose of daily inhaled corticosteroid medication (ICS) for asthma control equivalent to 88mcg of fluticasone or greater for at least 6 weeks from the time of enrollment. Participant must be on National Asthma Education and Prevention Program (NAEPP) controller step 2, 3 or 4.
Currently with mild GERD symptoms reported at V1 defined by a score on the Pediatric GERD Symptom Assessment Score greater than 15 and less than 80. GSAS ranges from 0 to >440.

Patient Q&A Section

What are common treatments for gastroesophageal reflux?

"Common treatments for gastroesophageal reflux include medications used in the treatment of H. pylori (proton pump inhibitors, clarithromycin, levofloxacin, and amoxicillin) and prokinetics (metoclopramide, domperidone, and nisoldipine). Less common options include proton pump inhibitors, achlorhydria stimulants (such as domperidone), and pyridostigmine bromide." - Anonymous Online Contributor

Unverified Answer

Can gastroesophageal reflux be cured?

"There is a low probability that GER could be cured. In patients with GER symptomatically managed, symptoms can often be treated with medication. It is suggested that patients with gastric reflux and symptoms be re-examined for esophageal reflux, gastric reflux, reflux esophagitis and/or Barrett's esophagus. Furthermore, there is a good chance that medication is not curative for patients with severe symptoms, and so alternative therapeutic techniques that may improve symptoms are appropriate." - Anonymous Online Contributor

Unverified Answer

What are the signs of gastroesophageal reflux?

"If symptoms do not resolve within 2 weeks, then symptoms of reflux should be followed up. If symptoms remain, this has potential consequences. Symptoms include headache, [back pain](https://www.withpower.com/clinical-trials/back-pain), abdominal pain, and nausea and vomiting (due to refluxed gastric contents)." - Anonymous Online Contributor

Unverified Answer

What is gastroesophageal reflux?

"Gastrointestinal symptoms are commonly reported in adult populations, and studies in children indicate that prevalence is as high as 6%. A definition of gastroesophageal reflux disease does not appear to exist, and the condition is still primarily diagnosed by endoscopy. At present, it appears that gastroesophageal reflux is not a serious or disabling disease." - Anonymous Online Contributor

Unverified Answer

What causes gastroesophageal reflux?

"Acid reflux causes about half of oesophageal mucosal erosions. A correlation has also been established between reflux-induced damage and the presence of autoimmune disease. The precise pathogenesis of these disorders is still a matter of discussion between various researchers." - Anonymous Online Contributor

Unverified Answer

How many people get gastroesophageal reflux a year in the United States?

"Approximately 5 billion people were impacted by GERD based on either diagnosis or treatment. GERD was the most common reason for visit to the physician among adults in the USA. GERD may be under-reported among patients with asthma, and as a reason for visit to the physician." - Anonymous Online Contributor

Unverified Answer

Is commercially available lansoprazole typically used in combination with any other treatments?

"Lansoprazole was commonly used in combination with other drugs and is considered appropriate for use in combination therapy with antibiotics for eradicating H. pylori. There is no evidence to show that the efficacy of lansoprazole was worse when used in combination therapy with other drugs." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of commercially available lansoprazole?

"In most studies with commercial lansoprazole, patients who received lansoprazole had statistically significantly lower discontinuation rates than placebo-treated patients. It is plausible that lower treatment discontinuation rates were primarily due to decreased GI side effects with lansoprazole compared with placebo treatment." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for gastroesophageal reflux?

"Clinical trials are an important tool to improve health outcomes and reduce health care costs for people with gastroesophageal reflux disease. A key prerequisite for trial registration, including patient and professional selection guidelines, was not evident in the gastroenterology literature. Clinical trials are usually performed in people with severe disease, which may be uncommon among people with the gastroesophageal reflux disease. There is a need for a process for identifying persons who might benefit from clinical trials." - Anonymous Online Contributor

Unverified Answer

What is commercially available lansoprazole?

"The majority of participants received lansoprazole 40 mg/d, with most of them in good adherence. The commercial product name did not vary from that of the brand name, and there were minimal differences between both in absorption, absorption, maximum concentration, and AUC." - Anonymous Online Contributor

Unverified Answer

What is the latest research for gastroesophageal reflux?

"There is compelling evidence supporting the effectiveness of treatment for GERD by PPI plus H2 blocker or antacids alone. The PPI does not appear to be necessary in those who achieve normalization of pH but has been shown to reduce the likelihood of recurrence. PPI and H2 blocker combination treatment options offer both effective symptom control and eradication of oesophageal acid reflux disease, without significant adverse effect. However, there is no evidence of PPI or H2 blocker dependence. More studies are required to make reliable predictions in the future of this evolving treatment option." - Anonymous Online Contributor

Unverified Answer

How does commercially available lansoprazole work?

"Recent findings of this randomized, double-blind, crossover trial suggest that lansoprazole 20 mg is effective at controlling reflux symptoms. Because lansoprazole is absorbed in a rapid and sustained manner at gastrointestinal pH (pH 3), this study supports additional investigation to identify dosage regimens that minimize the gastrointestinal symptoms." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Asthma by sharing your contact details with the study coordinator.